IT Business Analyst & Project Manager - 13376

Somewhere; Johannesburg; Remote; ZAR 200,000 - 300,000; Full time

Job summary

A leading company is seeking an experienced IT GxP Business Analyst & Project Manager. This pivotal role involves aligning enterprise technologies with business strategies, ensuring compliance, and driving project execution. The ideal candidate will have a strong background in biopharma business analysis and project management, with qualifications in a relevant technical field.

Qualifications

• Bachelor's degree in a relevant technical field.
• Experience in GxP Biopharma and project management.
• Proficiency in ITIL-based service management.

Responsibilities

• Lead design and implementation of IT projects following SDLC methodologies.
• Manage GxP-regulated projects, ensuring compliance.
• Promote a collaborative team culture across stakeholders.

Skills

GxP Biopharma Business Analysis

Project Management

Requirements Gathering

Compliance Management

Process Improvement

Education

Bachelor's degree in a science-related or technical field

Tools

GAMP5

Agile

Waterfall

ITIL

Job description

IT Business Analyst & Project Manager - 13376

Job Title: IT GxP Business Analyst & Project Manager
Location: Remote (Must be available during U.S. Eastern business hours)
Salary Range: $3,500 - $5,500 USD/month
Position Overview

We are seeking an experienced IT GxP Business Analyst & Project Manager to lead the alignment of evolving enterprise technologies with critical business strategies. This role is pivotal in translating complex Clinical, Regulatory, and Quality business needs into actionable systems and design specifications. It requires both strategic vision and hands-on project execution, with a strong emphasis on regulatory compliance, process improvement, and cross-functional collaboration.
Key Responsibilities

• Lead the design and implementation of IT projects following SDLC methodologies.
• Facilitate requirements-gathering sessions across Clinical, Regulatory, Quality, and IT teams.
• Analyze and improve business systems and workflows; identify compliance risks and process inefficiencies.
• Translate business requirements into system specifications, guiding software development, testing, and validation activities.
• Implement governance processes ensuring GxP, GDPR, HIPAA, and SOX compliance.
• Manage the full lifecycle of GxP-regulated projects: develop timelines, track deliverables, and ensure on-time execution.
• Provide clear, consistent communication and reporting across cross-functional stakeholders.
• Monitor and address project risks, proactively managing issues to maintain momentum.
• Promote a collaborative, accountable team culture.

Qualifications

Education:

• Bachelor's degree in a science-related or technical field.

Experience:

• Strong background in GxP Biopharma Business Analysis & Project Management.
• Experience gathering and documenting requirements for practical implementation.
• Proficiency in ITIL-based service management and software development oversight.
• Familiarity with methodologies such as GAMP5, Agile, and Waterfall.
• Experience with Clinical systems (CTMS, EDC, eTMF, SCE) - preferred.
• Experience with Quality systems (QMS, QDocs) - preferred.
• Availability to work aligned with U.S. Eastern Time Zone.

Certifications (preferred but not required):

• PMP, ITIL, or PRINCE2